Rituximab and Bendamustine in very old patients or old and medically unfit patients with CD20-positive B-cell lymphoma

Phase 1

• Conditions: Very elderly or elderly medically non fit patients with aggressive CD20 positive B-cell lymphoma; MedDRA version: 20.0Level: PTClassification code 10003899Term: B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024004-98-DE
• Lead Sponsor: niversity Medicine Göttingen Dept. Hematology and Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-19
• Study Completion: 2018-07-02
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

•Histologically confirmed CD20 positive aggressive lymphoma,
•Aany stage according to Ann Arbor Classification,
•Any IPI score,
•Life expectancy of at least 6 week at study beginn
•Age = 81 (completed) or age 61 to 80 (completed, including time period until the day before the 81st birthday) and CIRS > 6 and not qualifying for CHOP-therapy
•Ability to give informed consent
•Written informed consent
•ECOG <4 determined during prephase treatment before the first rituximab application
•gender: any
•Contract of participation signed by the study centre and sponsor

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Already initiated lymphoma therapy (except for the prephase treatment up to the first Rituximab application as specified for this study)
•Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement), in particular:
•angina pectoris CCS >2, cardiac failure NYHA >3
•FeV1<50% and/or a diffusion capacity <50% of the reference values
•creatinin clearance < 10 ml/min (Cockcroft-Gault)
•total bilirubin > 3 mg/dl
•Uncontrollable diabetes mellitus (prephase treatment with prednisolone!)
•Platelets <100 000/mm3, leukocytes <2500/mm3 (if not due to lymphoma)
•Known hypersensitivity to the medications to be used
•HIV-positivity
•Acute or chronic active hepatitis
•Poor patient compliance
•Simultaneous participation in other treatment studies
•Prior chemo- or radiotherapy, long-term use of systemic corticosteroids or anti-neoplastic drugs for previous disorder
•Other concomitant tumour disease and/or tumour disease in the past 5 years (except basalioma of the skin and carcinoma in situ)
•CNS involvement of lymphoma (intracerebral, meningeal, intraspinal)
•Active serious infections not controlled by oral or intravenous antibiotics or anti-fungal
•Any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk.
•Non-conformity to eligibility criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary endpoint for efficacy is the 2 years progression free survival. The primary endpoint for feasibility are therapy-associated deaths, frequency of grade 3&4 adverse events and SAEs, adherence to the protocol (as determined by cumlulative dose and time plot). ;Secondary Objective: 2 year overall survival, event-free survival, complete remission rate, partial remission rate, rate of primary pogression, relapse rate, ability for self-care and quality of life assessed by geriatric assessment and EORTC-QLQ-C30, patient satisfaction (CTQS);Primary end point(s): Primary endpoints for efficacy: 2 years progression free survival (PFS).<br>Primary endpoints for feasibility: therapy-associated deaths, frequency of grade 3&4 adverse events and SAEs, adherence to the protocol (as determined by cumulative dose and time plot) <br>;Timepoint(s) of evaluation of this end point: Planned evaluation of primary endpoint: 8/2018

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 2 years overall survival (OS), event-free-survival (EFS), complete remission rate (CR) and partial remission rate (PR), rate of primary progression, relapse rate, ability for self-care and quality of life assessed by geriatric assessment and EORTC-QLQ-C30, patient satisfaction (CTQS);Timepoint(s) of evaluation of this end point: Planned evaluation of secondary endpoint: 8/2018